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Psychedelic

Psilocybin for Major Depressive Disorder

Phase 2
Waitlist Available
Led By Scott Aaronson, MD
Research Sponsored by Sheppard Pratt Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline (day -1) to three weeks post-dose.
Awards & highlights

Summary

This trial is testing whether psilocybin can help improve depressive symptoms in adults with bipolar disorder.

Eligible Conditions
  • Major Depressive Disorder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline (day -1) to three weeks post-dose.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (day -1) to three weeks post-dose. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Montgomery-Asberg Depression Rating Scale (MADRS)

Side effects data

From 2021 Phase 2 trial • 95 Patients • NCT02061293
9%
Nausea
7%
Pain
7%
Viral upper resp. tract infection
7%
Back pain
7%
Bronchitis
4%
Oropharyngeal pain
4%
Suicidal Ideation
4%
Insomnia
4%
Influenza
4%
Depression
4%
Diarrhea
4%
Headache
4%
Sinus headache
4%
Depressed mood
4%
Lower resp. tract congestion
4%
Alcohol withdrawal syndrome
2%
Rhinorrhea
2%
Musculoskeletal pain
2%
Oedema
2%
Pyrexia
2%
Peripheral swelling
2%
Restlessness
2%
Vomiting
2%
Fungal infection
2%
Hypoesthesia
2%
Thrombocytosis
2%
Eye infection
2%
Constipation
2%
Dermatitis contact
2%
Bronchitis bacterial
2%
Traumatic lung injury
2%
Hyponatremia
2%
Arthralgia
2%
Pain in extremity
2%
Dizziness
2%
Migraine
2%
Sedation
2%
Anger
2%
Anxiety
2%
Cough
2%
Sexual abuse
2%
Sinus congestion
2%
Malignant melanoma
2%
Endodontic procedure
2%
Mallory-Weiss Syndrom
2%
Anemia
2%
Influenza like Illness
2%
Gingivitis
2%
Arthoscopic surgery
100%
80%
60%
40%
20%
0%
Study treatment Arm
Diphenhydramine
Psilocybin

Trial Design

1Treatment groups
Experimental Treatment
Group I: PsilocybinExperimental Treatment1 Intervention
25mg of Psilocybin
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psilocybin
2021
Completed Phase 2
~750

Find a Location

Who is running the clinical trial?

Sheppard Pratt Health SystemLead Sponsor
21 Previous Clinical Trials
7,794 Total Patients Enrolled
COMPASS PathwaysIndustry Sponsor
14 Previous Clinical Trials
1,543 Total Patients Enrolled
Scott Aaronson, MDPrincipal InvestigatorSheppard Pratt Health System
3 Previous Clinical Trials
842 Total Patients Enrolled
~3 spots leftby Jul 2025